Batch Record/Batch History Clause Samples

Batch Record/Batch History. All documentation associated with the manufacturing, testing, and release of a batch of API or drug product. The batch record gives specific instructions on the procedures, calculations, criteria, sampling, storage conditions and testing performed on a product and includes a listing of personnel participating in the production and the equipment and raw materials used during the process. The original, approved batch record that serves as the template to be completed for each production run is referred to as the Master Batch Record. Bulk Drug Product: Product that is held in bulk prior to being packaged. Certificate of Analysis (COA): A document detailing test procedures, specifications and results and signed by an appropriate second party to assure results are accurate and complete. Deviation: A departure from an approved instruction or established standard. A deviation may be planned to allow a change within cGMP procedures if it does not impact product strength, identity, safety, purity or quality. An unplanned deviation is a departure from cGMP practices which has the potential to impact product strength, identity, safety, purity, quality or usability. Deviation, Major: An occurrence that is a significant departure from documented procedures or specifications that could adversely impact the product quality and may require good scientific review or medical judgment to resolve. Examples include, but are not limited to, charging of incorrect materials, equipment malfunctions during critical operations, or failures during AQL inspections.